Quick summary
Quick summary: Trudell Sterile Water. Date: 2023-12-13.
Public recall detail
Trudell Sterile Water
2023-12-13
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Trudell Sterile Water. Date: 2023-12-13.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandTrudell Healthcare Solutions Inc.
ProductTrudell Sterile Water
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-74732
Affected products
ProductSterile Sodium Chloride 0.9%
Lot23045255 23045267 22083862 21122503 22114365 22022860
ModelT167007
Serial number23045255 23045267 22083862 21122503 22114365 22022860
DescriptionSterile Sodium Chloride 0.9%
ProductSterile Water
Lot23055524 22022859 22083878
ModelT167005
Serial number23055524 22022859 22083878
DescriptionSterile Water
Issue
There are products in distribution for which the required sterility assurance level (SAL) of 10-6 cannot be guaranteed. Recall start date: November 16, 2023
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - General hospital and personal use
CompaniesTrudell Healthcare Solutions Inc. 758 Baransway Drive, London, Ontario, Canada, N5V 5J7
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74732
Background{}
CompaniesTrudell Healthcare Solutions Inc. 758 Baransway Drive, London, Ontario, Canada, N5V 5J7
AudiencesHealthcare Industry
Source updated2023-12-13
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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